Automated urine collector-analyzer

ABSTRACT

A collector-analyzer apparatus for urine has a urine collecting tube joined with a urine receiving canister. Suction is produced in the collecting tube to join the tube with a penis or to the exterior surface of a female urethra orifice. Once suction is achieved the collecting tube stays in place by suction action. When urine flows into the urine collecting tube a sensor triggers a vacuum pump to produce a higher level of suction to flush the urine into the canister where a level sensor determines the quantity of urine received or resident within the canister. Various sensors in the canister determine levels of non-urine partials such as occult blood, drugs, salt, and other substances. When urine is no longer detected within the urine tube, the vacuum pump is turned off and a low-level vacuum remains to assure interconnection between the urine tube and the urethra.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority from prior U.S. provisional patentapplication Ser. No. 62/297,096 filed Feb. 18, 2016, the entiredisclosure of which is incorporated herein by reference.

This application is a continuation-in-part of prior U.S. non-provisionalpatent application Ser. No. 15/412,049 filed Jan. 22, 2017, the entiredisclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to the collection of body fluids,particularly urine, and to a method of automated collection and analysis

Brief Discussion of the Related Art

Male urinary collection and analysis is common for medical reasons. Thisis managed in the prior art with absorbent diapers, indwelling urinarycatheters and/or external, non-invasive urine collection devices.Diapers are associated with a high rate of skin breakdown and decuitusulcer formation while indwelling urinary catheters are a leading causeof urinary tract infections. Accordingly, there has been a great demandfor non-invasive external incontinence devices for collecting humanurine without exposing the body to continuous urine contact. To avoidleakage, prior art external, non-invasive devices for collecting urine,as exemplified by U.S. Pat. No. 5,263,947 to Kay, U.S. Pat. No.5,827,247 to Kay and U.S. Pat. No. 5,830,932 to Kay, have incorporated apara-metal seal formed of a ring or annular arrangement of leaves orpetals carried by a urine drainage housing and adapted to be adhesivelysecured to the end of the penis to produce a seal preventing leakage ofurine. To enhance the seal, additional sealing layers have beenproposed; however, such sealing layers are frequently appliedincorrectly when the application requires that the individual applyingthe device independently establishes an optimal accurate application ofthe additional sealing layer(s). Application of the additional sealinglayer(s) is commonly inaccurate, with the additional sealing layer(s)being applied too proximal or too distal to another sealing layer(s) orwith inadequate alignment to achieve an optimal bilaminar seal. Eachadditional sealing layer must be applied in a specific spatialorientation with respect to previously applied sealing layers, tooptimize the leak-free duration of each device application. Therefore,there is a need for an external incontinence device which can be appliedwith a consistent spatial orientation to allow leak-free use especiallyfor females. Furthermore, there is a need for a collection device withanalytic capabilities.

Brief discussion of related analytics: These devices are known inapplications for sensing protein, screening for diseases, detection ofNanocantilevers point mutations, blood glucose monitoring, detection ofchemical and biological warfare agents, and have been used innanoelectromechanical systems. Molecules adsorbed on a microcantilevercause vibrational frequency changes and deflection. Viscosity, density,and flow rate can be measured by detecting these physical changes. Thisdevelopment has increased the sensitivity limit to the extent thatresearchers can now visualize the counting of molecules. With theability of high throughput analysis of analytes and ultra-sensitivedetection, this technology holds promise for the next generation ofminiaturized and highly sensitive sensors. Molecular diagnostic devicesare getting smaller with the advancement of miniaturization techniques.There is increasing interest in the field of biosensor research onminiaturized platforms. Miniaturization is essential for in-vivophysiological monitoring, multiple specificity sensor arrays, sensorportability and minimized sample volumes. Conventional biosensors needextensive packaging, complex electronic interfacing, and regularmaintenance. These new micro-sensors have advantages over conventionalanalytical techniques in terms of high sensitivity, low cost, simpleprocedure, low analyte requirement, non-hazardous procedures, and quickresponse.

Sodium Chloride: A poly-silicon nanowire is used to sense and measuresodium chloride concentration in solution. The Department ofCommunications Engineering, at Yuan Ze University, Taiwan, has developeda NaCl concentration; ion sensitive field-effect transistor; usingpoly-silicon nanowires. This sensor was fabricated by a top-downtechnique for sodium chloride concentration measurement. The resultsshowed that the smallest threshold voltage and the best resolution were1.65 V and 0.41 μM, respectively. This sensor is able to be reused morethan 50 times while maintaining acceptable performance and showed goodlinearity of calibration within a wide range of concentrations. Based onthese results, the proposed sensor has the potential to be used formeasuring complicated samples with suitable modification on the surfaceof nanowires.

Moisture: In yet another development, Professor Alan Lakso of CornellUniversity has engineered a microchip which is able to hold water in asmall cavity and exchange moisture from that cavity with moisture in itsenvironment via a nanoporous membrane. The chip measures any changes inthe pressure within the cavity that result from water entering or beingdrawn out. In order to relay the data it gathers, the chip may be wiredto a Wi-Fi card, a data logger, or another device for gathering andtransmitting information. The chip can last outdoors for at least a fewyears, although freezing temperatures may cause failure.

Liquid Level: For liquid level sensing, optical infrared devices arecommercially available and can be used to replace mechanical type floatswitches while providing high precision level control. These deviceshave compact construction with no moving parts so as to provide highreliability. They meet or exceed all common safety standard and are RoHScompliant. Alternately, ITV plc of the UK produces a water level sensorpart number 6336 commonly used for this intended purpose.

Occult Blood: For occult blood detection, optical sensors are available,as for example from Sonotec Products, EU. to detect the smallest amountsof blood in dialysates on transparent tubes non-invasively. As thewavelength is adapted to the transmittance of blood, the internationalstandard IEC 60601-2-16:2008 for medical electrical devices is fulfilledreliably. Hence, these sensors are able to detect as small as 0.04% ofblood in an isotonic saline solution. For instance, one suchcommercially available detector meets high safety standards and featuresa serial interface. With simple commands, this sensor can be tested andits sensitivity level adjusted. Such a device is suitable for all tasksthat require the optical detection of transmission differences ofliquids in transparent tubes. Due to the high sensitivity of thesensors, it is even possible to detect when a tube filled with a clearfluid is empty.

Drugs: The Amedicheck Panel Urine Drug Testing Cup is available throughTransMed Co. LLC, Cumming, Ga. This device is used to determine thepresence of the following substances: Marijuana (THC), Opiates (OPI),Methamphetamines (METH), Cocaine (COC), Phencyclidine (PCP),Amphetamines (AMP), Oxycodone (OXY), Barbiturates (BAR), Benzodiazepine(BZO), Methadone (MTD), Tricyclic Antidepressants (TCA), and Ecstasy(MDMA).

Proteins: Recently, numerous biosensors for detecting specificbiomolecules such as DNA, proteins, and antibody-antigen have beenstudied for a clinical and industrial demand with the progress of lifescience. There has been considerable attention directed to proteinmolecules since the occurrence of disease is well known at this level.Even though several techniques for the detection of proteins such asoptical, mass spectrometry, and electrochemical measurement are inexistence, field effect transistor based biosensors, which arefabricated by semiconductor integrated circuit techniques, have latelyattracted attention because of its various advantages inminiaturization, standardization, mass-production and especiallysuitable configuration for an on-chip integration of both the sensor andmeasurement system. A gate field effect transistor biosensor for thedetection of streptavidin-biotin protein complexes in a siliconmicrofluidic channel has been developed. The connection between thisdevice and a microfluidic system could be achieved offering merits ofisolation between the device and solution, compatibility with integratedcircuit technology and applicability to the total analytical system.Such a device was fabricated combining semiconductor integrated circuitand micro-electro-mechanical system techniques.

SUMMARY OF THE INVENTION

The presently described apparatus includes a urine tube and a canister.The urine tube is adapted for joining with the human urethra, eithermale or female, and as such, enables reception of urine discharges. Asuction of about five inches Hg is produced within the apparatus. Thissuction enables the temporary joining between the interface portion andthe urethra. The apparatus is worn at times when urination is expectedor desired and may be disconnected and removed from, and reconnected toan individual at will. The urine tube is adapted by size for receivingan individual's penis or with a flared end to engage a female urethrawherein both cases suction is used for engagement. Once sealed, thesuction source may be released while leaving a low vacuum within theurine tube thereby maintaining the seal. In both the male and femaleapproach, suction within the tube may be released at any time byreleasing suction. However, suction is present during urination whichwill send urine into the urine canister. A liquid sensor signals whenurine is present. This produces a higher suction level within the urinetube, drawing the urine into the canister. When the liquid sensor nolonger senses the presence of liquid, the vacuum generator closes-downwhile leaving a low-level suction for maintaining a connection of theurine tube to the urethra. Sensors within the canister are able todetect substances within the urine. For instance, using known sensorsand analytic techniques: Quantitative analysis of occult blood,proteins, glucose, drugs, and various chemical compositions can bedetermined. This information is delivered to a digital processor fordata logging and analysis including plotting values against time.Comparison of measured values relative to standards enables predictionof medical conditions including illness. Therefore, it is an object ofthe invention to maintain a tube at a urethra outlet. It is anotherobject to provide a means for allowing urination to occur withoutinterrupting a person's sleep or activities. It is a further object tocontinuously monitor a patient's biological signs through urine samplingand analysis. It is a still further object to collect urine in a systemthat is low cost, easily-operated, and portable to be useful byparamedics in the field. These and other aspects of embodiments hereindescribed will be better appreciated when considered in conjunction withthe following description and the accompanying drawings. It should beunderstood, however, that the following descriptions, while indicatingpreferred embodiments and numerous specific details thereof, are givenby way of illustration and not of limitation. Changes and modificationsmay be made within the scope of the embodiments herein presented withoutdeparting from the spirit thereof. Unless otherwise indicatedexpressions of singularity shall include a plurality and vice-versa,while expressions of the alternative shall be considered nonexclusive.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrations in the drawing sheets presented herein are examples onlyand should not be taken as limiting. The same reference numeral refersto the same element as it may appear in multiple figures and drawingsheets.

FIG. 1 is a proximal perspective view of an interface portion of adescribed apparatus showing a urine tube extending proximally from anenclosure;

FIG. 2 is a section view thereof taken along cutting plane line 2-2 inFIG. 1 and showing a penis interface with a urine tube;

FIG. 3 is a vertical section view of a typical female abdomen with aperitoneum area showing a urethral interface with a urine tube of theapparatus;

FIG. 4 is a perspective view of a garment interface with the urine tube;

FIG. 5 is a side elevation view of an enclosure of the apparatus;

FIG. 6 is a perspective view of an open top thereof showing componentsof a receiver portion of the apparatus;

FIG. 7 is a side view of a canister of the apparatus;

FIG. 8 is a front view of a vacuum gauge of the apparatus;

FIG. 9 is a schematic diagram of the apparatus defininginterconnections; and

FIG. 10 is a logic flow diagram illustrating the described method.

DETAILED DESCRIPTION

As shown in the attached drawing figures, a collector-analyzer apparatusincludes an interface portion 110 (FIGS. 1 and 2) and a receiver portion120 (FIGS. 5 and 6). These two portions are joined by a flexibleinterconnection tube 20 so that they may be conveniently set somedistance apart during operation.

As shown in FIGS. 1 and 2 interface portion 110 is adapted for joiningwith the urethra, either male or female, and as such, enables receptionof discharged urine; see the arrow labeled “fluid” in FIG. 2. Thesefigures illustrate penis 5 which is inserted into proximal open end 12of urine tube 10. Tube 10 may be of a transparent soft elastomericmaterial such as a silicone gel. Internal ribs 16 within tube 10 areshown, and it is pointed out that they provide improved gripping of tube10 around penis 5 so that penis 5 is secured within tube 10 by suctionaction with no leakage. Shown also, are a spherical enclosure 30, ventholes 36 to allow air to enter enclosure 30, and proximal entry 32 inenclosure 30 for holding tube 10 securely in place.

FIG. 2 illustrates further the character of interface portion 110including rigid disc 50 shown edgewise, which may be a circular flatobject secured by distal end 15 of urine tube 10. It is pointed out thaturine tube 10, being of an elastomeric material, may be stretched aroundthe periphery of disc 50 to hold it in place axially relative to urinetube 10. Disc 50 has a central hole 14 which accepts proximal end 22 ofinterconnection tube 20 securing it in place with a tight fit. Fluidsensor 62 may be mounted on disc 50 as shown, and as will be describedmay be functional in the process of generating suction when urine ispresent within urine tube 10. It is suction that draws urine from tube10 to tube 20. One or more electromechanical vent valves 40 arecontained within enclosure 30 and mounted through holes in disc 50 whichsecures valves 40 in place. Valves 40, when open, provide air flow intourine tube 10, but prevents fluid from passing outward (one-way valve).Valves 40 are of such size as to allow some air to enter tube 10, andwhile suction overcomes the tendency of pressure rising due to this airinflow, to maintain a negative pressure within tube 10 suction isincreased to compensate. Fluid sensor 62 may also have a companionsensor to monitor air pressure (suction). Connector 70 is used to allowseparation of interconnection tube 20 to allow a comfortable joining ofurine tube 10 with the penis 5 or the urethra which enables a user tomove about freely when the apparatus is not being used. Electricalinterconnections, (see FIG. 9) will also be disconnected at that time.An O-ring 72 is used to seal connector 70.

FIG. 3 illustrates the joining of urine tube 10 with the female urethra3 which drains the bladder 4, wherein suction is applied at the urethralorifice (endpoint of the urethra 3) which is adjacent to the tissuesurface of the vestibule. As shown, urine tube 10 may be flared orforced into a flared condition thereby acting as a suction-cup typejoint for improved suction holding.

FIG. 4 wherein urine tube 10 is engaged with an undergarment 80 such asunderwear, under-pant, panty, diaper or similar item when worn by anindividual when using the apparatus. As shown, urine tube 10 may beinserted through an opening or a slit, fold, etc. 82 in undergarment 80,wherein opening 82 may have a strong elastic edge or closure capable ofhelping to hold urine tube 10 in place so that axial movement betweenurine tube 10 and undergarment 80 is minimized and loss of suctionattachment is also minimized. In this case urine tube 10 is secured inplace by both garment 80 as well as by suction as previously described.

In FIG. 5 case 200 may include a hinged cover 205 as shown. Cover 205may have a digital processing system 208 mounted within. System 208 maybe a Seetec model W759 digital processor with seven-inch LCD monitorresistive touch panel and WIFI, Bluetooth, and GPS communicationcapability or any equivalent as will be known to those of skill in theart.

In FIG. 6, as shown, case 200 may enclose graduated canister 210 withits attached, sealed lid 215. Case 200 may also house motor drivenvacuum pump 220 with its attached shut-off valve 230 and vacuum gauge240. Suction tube 250, may interconnect shut-off valve 230 with canisterlid 215 and may include filter 260 which may be used to prevent vacuumpump oil from traveling upstream into canister 210 and also may preventbacteria from traveling downstream to reach pump 220 where it would beexhausted to the environment. Vacuum pump 220 may be powered by ACcurrent via power cord 270 as shown, or alternatively may be powered bya DC battery pack with an inverter (not shown). Suction (low pressure)in canister 210 is developed in interconnection tube 20 and urine tube10 for application at penis 5 or urethra 3 as previously described.Urine, when present, is therefore sucked through urine tube 10,interconnection tube 20, and into canister 210 where it can be analyzed.In like manner, other fluids may be suctioned into canister 210 foranalysis.

FIG. 7 illustrates graduated canister 210 with lid 215. As described,urine is delivered into canister 210 via interconnection tube 20 whichis fitted to inlet 217 of lid 215. Suction is applied at fitting 218 oflid 215. Sensors 280 a, 280 b, and 280 c are representative of a widevariety of sensor and sensory materials that may be utilized incharacterizing collected samples of urine or other fluids. Such sensorsmay be mounted, as shown, in strips on the interior side surface ofcanister 210 as shown, or may have another form and may be mounted inother ways. Such sensors may be used to detect liquid level, tracechemicals, biological agents, occult blood, and other foreign agents orcomponents of collected urine as described in the foregoing BriefDiscussion of Related Analytics.

FIG. 8 illustrates vacuum gauge 240 capable of reading vacuum in mm Hgon the inner scale and inches of Hg on the outer scale with highervacuum (stronger suction/lower pressure) increasing in acounter-clockwise movement of the gauge's indicator. Suction of about 5inches (145 mm) Hg is controlled as a maximum set point by gauge 240 sothat valve 230 is automatically closed when vacuum level attempts toexceed this value thereby preventing damage to the penis sheath or tothe tissues of the labia minora/vestibule. Vacuum operations include twomodes: Standby and Active. In Standby mode, a low level of suction iscreated after which vacuum pump 220 is shut down. This low level ofsuction maintains attachment of the proximal end 12 of urine tube 10 tothe penis or urethral aperture. During standby mode valves 40 and 230are held closed to preserve suction for the maintenance of attachment ofurine tube 10. Standby mode may be held throughout the night, but ifurine enters tube 10 while the system is in Standby mode, urine sensor62 immediately triggers Active mode operation through computer 208.Sensor 62 signals computer 208 which causes pump 220 to turn on andvalves 40 and 230 to open. Suction is generated at urine tube 10 whichovercomes air inflow through valves 40 to maintain suction which forcesurine through tubes 10 and 20 and into canister 210. When sensor 62 nolonger detects the presence of urine, the reverse occurs so that theapparatus resumes the Standby mode. In an alternate mode of operation,vacuum pump 220 may be on during standby to assure that enough suctionis produced to hold attachment of urine tube 10 as described above. FIG.10 shows the above operation in detail.

FIG. 9 shows how several interconnections between components of thedescribed system are joined. Computer 208 controls operations. Urinetube 10 is joined to the urethra by suction during Standby mode. Whenurine enters urine tube 10 urine-sensor 62 detects it and signalscomputer 208 which, in turn, signals vacuum gauge 240 and opens vacuumvalve 230 and also turns on vacuum pump 220. Computer 208 signals inletvalves 40 thereby opening them. With vacuum pump 220 operating and withvacuum valve 230 open, suction is applied through vacuum tube 250 andcanister 210 and interconnection tube 20 and urine tube 10 which flushesthe urine into canister 210. When urine sensor 62 no longer senses urinein urine tube 10 the signal to computer 208 is extinguished and signalsare sent to inlet valves 40 and, through vacuum gauge 240 to closevacuum valve 230 and close-down vacuum pump 220. In the alternative,standby mode may be entered with vacuum valve 230 and/or vacuum pump 220throttled to achieve a low suction level as monitored by vacuum gauge230. When urine is present in canister 210 sensors 280 determine thepresence and characterization of several species within the urine suchas proteins, drugs, occult blood, sodium chloride, and other elements,compounds, and substances. Such content may be determined down to microlevels using one or more of the techniques described in the foregoingBrief Discussion of Related Analytics herein. It is within the skilllevel of those experienced in the computer arts to define an algorithmor software program such as defined in FIG. 10 to carry out theprocesses described in FIG. 9. It is within the skill level of thoseexperienced in systems engineering to define a means for interconnectingthe components of the apparatus as shown in FIG. 9.

It should be recognized that the described apparatus may be adapted foruse with animals other than humans. For instance, there is a need fortaking and analyzing urine samples of farm animals such as horses,mules, cows, and non-farm animals and wild mammals.

In this description, embodiments are described as a plurality ofindividual parts, and methods as a plurality of individual steps andthis is solely for the sake of illustration. Accordingly, it iscontemplated that some additional parts or steps may be added, someparts or steps may be changed or omitted, and the order of the parts orsteps may be re-arranged while maintaining the sense and understandingof the apparatus and methods as claimed.

What is claimed is:
 1. A urine collector-analyzer apparatus comprising:a disk positioned within a vented spherical enclosure; a urine tubeengaged with and terminated within said spherical enclosure, wherein adiametrically stretched distal end of said urine tube is positionedaround a periphery of said disk for securement of said stretched distalend of said urine tube; a fluid sensor mounted on said disk for sensingfluid within said urine tube; an air vent valve mounted through saiddisk for injecting air into said urine tube; a vacuum pump engaged withan interconnection tube for establishing a suction level within saidurine tube and said interconnection tube; a proximal end of saidinterconnection tube extended into and secured by said sphericalenclosure wherein said interconnection tube extends through said diskterminating within said distal end of said urine tube; a distal end ofsaid interconnection tube terminated within a canister for collectingsaid fluid; said fluid sensor adapted for producing a first signal whensaid fluid is detected in said urine tube; a fluid level sensor withinsaid canister, said fluid level sensor adapted for producing a secondsignal, said second signal related to a fluid level within saidcanister; a signal processor adapted for receiving said first and saidsecond signals: said signal processor interconnected for control of saidvacuum pump and said air vent valve for adjustment of urine flow and forproducing a third signal when said fluid level equals a selected maximumfluid level, wherein said third signal identifies a need for service ofsaid canister.
 2. The apparatus of claim 1 further comprising a vacuumgauge interconnected with said interconnection tube for monitoring saidsuction level therein and for control by said signal processor.
 3. Theapparatus of claim 2 wherein said signal processor, said canister, saidvacuum gauge, and said vacuum pump are mounted within a case.
 4. Theapparatus of claim 3 wherein said signal processor is mounted within alid of said case.
 5. The apparatus of claim 1 wherein said urine tubehas a proximal end contoured for sealing a female's urethra.
 6. Theapparatus of claim 1 wherein said urine tube is contoured fortight-fitting around a penis when inserted therein.
 7. The apparatus ofclaim 1 further comprising a garment with an elastic aperture, saidelastic aperture elastically fitted with compressive gripping aroundsaid urine tube thereby securing said urine tube in place with respectto said garment.